Job title: quality systems section lead
this role is responsible for developing, establishing and maintaining quality management system programs, policies, processes, procedures, training materials, and controls to enhance the performance and quality of products.
main responsibilities:
* provide overall quality systems leadership, direction of personnel and activities of the team members.
* provide expert-level guidance and direction of the quality systems body-of-knowledge.
* identify opportunities to apply, continuously improve, and redefine quality management system and controls for all product-related processes in accordance with applicable regulations.
* aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
this position requires a bachelor's degree in engineering, science or a related technical field. Experience in quality roles, regulatory requirements, and organizational influence are also necessary.
the ideal candidate will have demonstrated extensive experience with domestic and international regulatory requirements, solid knowledge of working with international quality regulations, and experience managing quality management reviews, capa process, and internal and external audits.
a minimum of 4 years of experience in quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment is required. Additionally, fda class ii or class iii medical device experience, lead auditor/auditor certification, and ability to travel up to 15% are preferred.
benefits:
* career development with an international company where you can grow your career.
* access to resources, including training and development opportunities.
* opportunities for advancement and professional growth.
this role offers a chance to work on quality management systems, develop policies and procedures, and ensure compliance with regulatory requirements. If you are passionate about quality and want to make a difference, this may be the perfect opportunity for you.